Back to resultsPsoriatic Immune Response to Tildrakizumab
Primary Purpose
Psoriasis Vulgaris
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tildrakizumab Prefilled Syringe
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis Vulgaris
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Patients with moderate-severe psoriasis or > 5% body surface area affected.
Exclusion Criteria:
- taking systemic immunosuppressives in the last 4 weeks
- pregnancy
- severe immunodeficiency (either from genetic or infectious causes).
- tuberculosis or other active serious infection
- active systemic malignancy.
- breast-feeding
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Sites / Locations
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tildrakizumab treatment
Arm Description
Biological/vaccine: tildrakizumab
Outcomes
Primary Outcome Measures
Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment
Change in severity and extent of psoriasis (calculated by Psoriasis Area and Severity Index (PASI) score); scale range of 0 to 72, 72 being maximal disease.
Secondary Outcome Measures
Full Information
NCT ID
NCT05390515
First Posted
May 20, 2022
Last Updated
August 25, 2023
Sponsor
University of California, San Francisco
Collaborators
Sun Pharmaceutical Industries Limited
1. Study Identification
Unique Protocol Identification Number
NCT05390515
Brief Title
Psoriatic Immune Response to Tildrakizumab
Official Title
Psoriatic Immune Response to Tildrakizumab
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Sun Pharmaceutical Industries Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.
Detailed Description
This is a one-arm, open-label study to examine the effect of Tildrakizumab on cutaneous and blood immune cells of psoriatic patients. Ten subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tildrakizumab treatment
Arm Type
Experimental
Arm Description
Biological/vaccine: tildrakizumab
Intervention Type
Drug
Intervention Name(s)
Tildrakizumab Prefilled Syringe
Intervention Description
IL-23 inhibitor
Primary Outcome Measure Information:
Title
Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment
Description
Change in severity and extent of psoriasis (calculated by Psoriasis Area and Severity Index (PASI) score); scale range of 0 to 72, 72 being maximal disease.
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Patients with moderate-severe psoriasis or > 5% body surface area affected.
Exclusion Criteria:
taking systemic immunosuppressives in the last 4 weeks
pregnancy
severe immunodeficiency (either from genetic or infectious causes).
tuberculosis or other active serious infection
active systemic malignancy.
breast-feeding
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Cho, MD, PhD
Phone
415-575-0524
Email
rashes@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Cho, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Cho, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Psoriatic Immune Response to Tildrakizumab
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